Study to Evaluate Safety, Pharmacokinetics and Therapeutic Activity of RO6874281 as a Combination Therapy in Participants With Unresectable Advanced and/or Metastatic Renal Cell Carcinoma (RCC)



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:March 20, 2017
End Date:April 13, 2021
Contact:Reference Study ID Number: BP39365 www.roche.com/about_roche/roche_worldwide.htm
Email:global-roche-genentech-trials@gene.com
Phone:888-662-6728 (U.S. and Canada)

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An Open-Label, Multi-Center, Randomized, Dose-Escalation, Phase 1b Study to Evaluate Safety, Pharmacokinetics and Therapeutic Activity of RO6874281 in Combination With Atezolizumab ± Bevacizumab in Patients With Unresectable Advanced and/or Metastatic Renal Cell Carcinoma

This is an open-label, multi-center, randomized, Phase 1b, adaptive, clinical study to assess
the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary therapeutic
activity of RO6874281 in combination with atezolizumab with/without bevacizumab in
participants with unresectable advanced and/or metastatic RCC. The study will consist of a
dose-escalation part and an extension part.


Inclusion criteria:

- Unresectable advanced and/or metastatic RCC with component of clear cell histology
and/or component of sarcomatoid histology that has not been previously treated with
any systemic therapy, including treatment in the adjuvant setting

- During dose escalation only, an additional population with unresectable advanced
and/or metastatic 2nd line RCC patients is allowed

- At least one tumor lesion with location accessible to biopsy per clinical judgment of
the treating physician

- Consent to provide an archival tumor tissue sample (if available) and to undergo
baseline and on treatment tumor biopsies for pharmacodynamic biomarker analysis

- Measurable disease, as defined by RECIST v1.1. At least one lesion accessible for
biopsy

- Participants with unilateral pleural effusion are eligible if they fulfill both of the
following: (a) New York Heart Association (NYHA) Class 1; (b) Global initiative for
obstructive lung disease (GOLD) test level 1 (forced expiratory volume in 1 second
[FEV1]/ forced vital capacity [FVC] less than [<] 0.7 and FEV1 greater than or equal
to [>=] 80 percent [%] predicted after inhaled bronchodilator)

Adequate hematological function: neutrophil count of ≥1.5 ≥109 cells/L, platelet count of
≥100,000/≥L, Hb ≥9 g/dL (5.6 mmol/L), lymphocytes ≥0.8 ≥109 cells/L.

Exclusion Criteria:

- Symptomatic or untreated central nervous system (CNS) metastases

- Participants with asymptomatic CNS metastases with previous or concomitant brain
deficiencies, as defined in the protocol

- Participants with confirmed bilateral pleural effusion

- Episode of significant cardiovascular/cerebrovascular acute disease within 6 months
prior to Cycle 1 Day 1

- Active or uncontrolled infections

- Human immunodeficiency virus (HIV) or hepatitis B virus (HBV) or hepatitis C virus
(HCV) infection

- Major surgery or significant traumatic injury <28 days prior to Cycle 1 Day 1
(excluding fine needle biopsies) or anticipation of the need for major surgery during
study treatment

- Serious, non-healing wound; active ulcer; or untreated bone fracture

- Proteinuria as demonstrated by a urine protein to creatinine ratio (UPCR) of >=1.0 at
screening

- History of, active or suspicion of autoimmune disease

- Concurrent use of high dose of systemic steroids. The use of inhaled, topical and
ophthalmic steroids is allowed.
We found this trial at
5
sites
333 Cedar Street
New Haven, Connecticut 06520
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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22 South Greene Street
Baltimore, Maryland 21201
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Baltimore, MD
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303 East Superior Street
Chicago, Illinois 60611
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Chicago, IL
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610 University Avenue
Toronto, Ontario M5G 2M9
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Toronto,
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